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Headquartered in San Antonio, Texas, Summit Clinical Research is an Integrated Research Organization dedicated to Non-Alcoholic Steatohepatitis (NASH) clinical trials, that delivers a full spectrum of study enrollment and site enrichment services to sites and sponsors in our network. From our inception in 2018, Summit has increasingly built a leadership team of uniquely specialized physicians, and clinical operations team professionals that span the health care industry.

At Summit, we strive to be on the forefront of innovative research by continuing to educate and expand our knowledge in the ever-changing landscape of Liver Disease treatment. As a network, we build upon each other’s successes to empower and inspire one another to achieve greater heights. Summit Clinical Research is committed to company culture, employee retention, and superior therapeutic areas of focus.

To provide best quality sites to our sponsors around the world, Summit has expanded our network throughout the United States, Mexico, Puerto Rico, Germany, France, Italy, and Argentina.

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If you are a sponsor or research site interested in becoming part of our Non-alcoholic Steatohepatitis (NASH) clinical trial network, please contact Summit Clinical Research for more information.

Our Leadership

Chairman

Dr. Stephen Harrison

Dr. Harrison is a pioneer in the field of liver research, and specializes in both Gastroenterology and Hepatology.

Dr. Harrison earned his medical degree from the University Of Mississippi School Of Medicine. He completed his internal medicine residency and gastroenterology fellowship at Brooke Army Medical Center and a 4th year advanced liver disease fellowship at Saint Louis University. He is board certified in both internal Medicine and Gastroenterology. Dr. Harrison served as a Professor of Medicine at the Uniformed Services University of the Health Sciences and is currently a Visiting Professor of Hepatology at Radcliffe Department of Medicine, University of Oxford. He is a past Associate Editor for Hepatology and is currently an Associate Editor for Alimentary Pharmacology and Therapeutics. He is a peer-reviewer for over 20 medical journals and is internationally known for studies in Hepatitis C and Non- Alcoholic Fatty Liver Disease with over 180 peer reviewed publications in these fields.

Dr. Harrison most recently served as a Colonel in the United States Army. Retiring in 2016, he concluded 20 years of dedicated service to his country. During his Army tenure, he served as the Director of Graduate Medical Education at Brooke Army Medical Center, Associate Dean for the San Antonio Uniformed Services Health Education and Gastroenterology Consortium, and Gastroenterology Consultant to the Army Surgeon General.

Dr. Harrison specializes in both Gastroenterology and Hepatology. Dr. Harrison is a pioneer in the field of liver research, and he continues his pursuit of new treatment options and cures for liver disease as the Medical Director of Pinnacle Clinical Research.

President

Gail Hinkson

Gail has been involved with the conduct and oversight of human subject’s research and clinical trials since 1994.

Gail Hinkson has been involved with the conduct and oversight of human subject’s research and clinical trials since 1994. She served as Associate Director of Clinical Operations for a 130 bed early phase clinical research unit specializing in Phase 1 and 2 in-patient clinical trials. Her research experience includes management of late phase clinical research and human subject’s research in all major therapeutic areas acquired during her role of Clinical Trials Director for a 501c3 organization specializing in conducting research and education objectives within the United States Military and Federal Institutions. In addition, she has worked as the Clinical Research Director for an international medical device company.
Chief Medical Officer

Dr. Sophie Jeannin

Dr. Jeannin has actively participated in the advancement of NASH drug development, as the Working Group Co-Chair for Clinical Trial Endpoints, and Steering Committee Member of the Liver Forum.

Dr. Jeannin Megnien obtained her Medical Degree from Paris Medical University, France. She completed her internship in cardiovascular prevention in a Paris Hospital, and as a CRA/Project manager in Pharma clinical development. She has worked in the R&D and Clinical Development field for more than 25 years, with specific expertise in NASH & metabolic disease. Throughout her career, Dr. Jeannin has held international Project Manager positions, consulting positions in clinical development and quality management, for both pharma and biotech. Prior to joining Summit, Dr. Jeannin worked for 8 years as the Chief Medical Officer (CMO) for Genfit and has led the development program of the drug candidate elafibranor in NASH and PBC. She has brought the drug forward from the initial phase 2b to the current phase 3 registration trial for NASH. Dr Jeannin has actively participated in the advancement of NASH drug development, as the Working Group Co-Chair for Clinical Trial Endpoints, and Steering Committee Member of the Liver Forum. She has coordinated and participated in multiple regulatory meetings as Sponsor CMO, both in Europe and in the US.
Chief Scientific Officer

Mazen Noureddin, MD, MHSc

Dr. Noureddin is internationally known for his research in the area of NAFLD/NASH and NASH related cirrhosis. He conducted more than 40 investigational clinical studies of novel treatments for NASH.

Dr. Noureddin is the founding director of the Fatty Liver Program at Cedars-Sinai Medical Center (currently ranked #2 in GI and GI surgery per US News). Dr. Noureddin did his internal medicine residency at the University of Southern California (USC) and then moved to the National Institutes of Health (NIH), where he enrolled in a three-year hepatology fellowship at the Liver Diseases Branch of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). There, he finished the NIH/Duke University Master of Health Sciences in Clinical Research program. After completing his NIH fellowship, he completed a gastroenterology fellowship at the University of California, San Diego (UCSD), where he was a T32 NIH fellow. He then joined the University of Southern California (USC) as an Assistant Professor of Clinical Medicine in 2013. He was then recruited to Cedars-Sinai Medical Center in 2015 to establish its new fatty liver program.

Dr. Noureddin is internationally known for his research in the area of NAFLD/NASH and NASH related cirrhosis. He conducted more than 40 investigational clinical studies of novel treatments for NASH. In addition, he is an expert in non-invasive testing and biomarkers of the field, especially serum biomarkers, trainset elastography, and magnetic resonance imaging techniques. He has published in all these areas and has been invited to consensus panels on this topic by multiple societies including the American Association for the Study of Liver Diseases (AASLD) and European Association for the Study of Liver Diseases (EASL). He has given invited lectures on NAFLD/NASH at national and international society meetings and serves on several steering committees/advisory boards for industry. He is the vice chair of the AASLD NASH special interest group (will be chairing the group in 2023) and serves on the editorial board for major GI journals including “Gastroenterology”, “Hepatology” and “Clinical Gastroenterology and Hepatology (CGH)”. He is one of the new Associate Editors of “Clinical Gastroenterology and Hepatology (CGH)” starting 2022. He is funded by the National Cancer Institute and has served as a reviewer on NIH study section. He has published in many journals including: The Lancet, Science Trinational Medicine, Journal of Hepatology, Journal of Clinical Investigation, Gastroenterology, Hepatology, Clinical Gastroenterology and Hepatology and others

Chief Operations Officer

Genevieve Long

Genevieve has a wide variety of Phase 0-IV research experience across multiple therapeutic areas which included on-site clinical research management.

Genevieve Long started her career in arctic wildlife research and happily fell into clinical research in 2001. She has a wide variety of Phase 0-IV research experience across multiple therapeutic areas which included on-site clinical research management, development and implementation of a Quality Control Quality Assurance program and the creation of the organizations Lean-six Sigma initiative yielding over 1.1M in savings within its first year of implementation. She has also worked for a large Non-profit organization managing Federally funded clinical research contracts worth an estimated $15-20M including vaccine development of two novel compounds through manufacturing, pre-clinical testing and into clinical trials. Genevieve joined Summit Clinical Research in October 2018 and serves as the Director of Operations.

How our Integrated Research Organization works

What our partners are saying about us…

We have been extremely pleased with the close collaboration developed with the Summit Research Network that enabled a speedy recruitment of our AXA1125-003 trial. This collaboration allowed us to optimize recruitment (both speed as well as the quality of study participants), and with the right mix of study investigators who are deeply vested in the care of NASH patients.

Dr. Manu ChakravarthyCMO, Axcella Health

Summit’s leadership team offers superb therapeutic area expertise, with a proven record in study design, patient enrollment, and data interpretation. Every sponsor interested in NASH trials should explore Summit as a potential partner.

Dr. Hubert ChenMetacrine, Inc.

We value our collaboration with Summit Clinical Research, which allowed us to close the enrollment of our NASH phase 2 study 3 months ahead of the initial timelines. Summit’s collaborative model worked very smoothly with the CRO and other vendors, based on clear communication channels and responsibilities.

Sujal ShahCymaBay Therapeutics

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